Pharmaceutical Operations Manager

Job Description

The Pharmaceutical Operations Manager – Sterile Manufacturing is responsible for managing all aspects of sterile drug product manufacturing to ensure compliance with cGMP standards and regulatory expectations (FDA, EMA, etc.). This role focuses on aseptic processing, cleanroom operations, and ensuring the delivery of high-quality sterile products while maintaining safety, efficiency, and compliance in a highly regulated environment.

Key Responsibilities:

Lead daily operations for sterile manufacturing, including aseptic filling, terminal sterilization, and lyophilization, as applicable.

Ensure strict adherence to current Good Manufacturing Practices (cGMP), FDA 21 CFR Part 210/211, EU Annex 1, and site Standard Operating Procedures (SOPs).

Manage and develop production teams across multiple shifts, ensuring aseptic behavior and cleanroom discipline are maintained.

Collaborate with QA/QC, Validation, Engineering, and Supply Chain to ensure readiness for batch manufacturing, on-time delivery, and audit preparedness.

Oversee environmental monitoring compliance, gowning practices, and cleanroom behavior to ensure sterility assurance.

Drive continuous improvement initiatives using lean and Six Sigma tools to increase efficiency and reduce risk.

Participate in investigations, deviations, CAPAs, and root cause analysis related to aseptic processing and sterile failures.

Support regulatory inspections and customer audits; serve as SME (Subject Matter Expert) for sterile manufacturing processes.

Monitor and manage KPIs such as batch success rate, OEE (Overall Equipment Effectiveness), right-first-time metrics, and compliance indicators.

Ensure proper training, qualification, and ongoing competency assessments for aseptic operators and support staff.

Qualifications:

Bachelor’s degree in Pharmacy, Microbiology, Biochemistry, Chemical Engineering, or a related field (Master’s preferred).

Minimum 7 years of experience in pharmaceutical manufacturing, with at least 3 years in sterile/aseptic operations and people management.

In-depth knowledge of sterile manufacturing requirements, cleanroom operations, aseptic techniques, and contamination control strategies.

Familiarity with isolator technology, RABS (Restricted Access Barrier Systems), and automated aseptic filling lines.

Demonstrated ability to lead cross-functional teams in a high-compliance, high-risk production environment.

Excellent leadership, decision-making, and communication skills.

Experience with regulatory inspections (FDA, MHRA, EMA) and responding to observations.

Preferred Certifications:

Lean Six Sigma (Green or Black Belt)

Sterile Manufacturing or Aseptic Processing Training Certification

Full-time